Actavis can launch generic painkiller in May 2014 under settlement
PARSIPPANY, N.J. — Actavis and Mallinckrodt have reached a settlement concerning the former’s generic version of an opioid painkiller made by the latter, Actavis said Thursday.
The companies settled patent lawsuit regarding Actavis’ generic version of Mallinckrodt’s Exalgo (hydromorphone hydrochloride) extended-release tablets in the 32-mg strength. The companies settled litigation regarding the 8-mg, 12-mg and 16-mg strengths last month.
Under the settlement, Mallinckrodt granted Actavis a loyalty-free license to its U.S. patents on Exalgo, allowing Actavis to start selling the 32-mg strength in generic form starting in May 2014. Actavis said it was likely the first company to file for Food and Drug Administration approval of a generic version of the drug, which would entitle it to 180 days in which to compete exclusively against the branded version after approval.
Eisai receives orphan drug designation for thyroid cancer drug
WOODCLIFF LAKE, N.J. — The Food and Drug Administration has granted special designation to a drug made by Eisai for treating thyroid cancer.
The drug maker said Thursday that its experimental drug E7080 (lenvatinib) had received orphan drug designation from the FDA for follicular, medullary, anapestic and metastatic or locally advanced papillary thyroid cancer.
The FDA grants the designation under the Orphan Drug Act for products that treat, diagnose or prevent a rare disease or disorder affecting fewer than 200,000 people in the United States. Orphan drug designation entitles a company to tax credits, extended market exclusivity following regulatory approval and other benefits.
United Therapeutics resubmits application for pulmonary arterial hypertension drug
SILVER SPRING, Md. — The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said Thursday.
The FDA originally declined to approve the drug, treprostinil diolamine extended-release tablets, in a letter submitted to the company in October 2012.
The agency plans to decide whether or not to approve the drug in March of this year, United Therapeutics said.